News Digest 27.12.2024 — 10.01.2025
Regulators
The work of the commission on simplified registration of potentially defective medical devices has been extended until 2028
Roszdravnadzor has approved a departmental order, according to which, from January 1, 2025 until the same date in 2028, the validity of order No. 8003 of November 13, 2023 on the interdepartmental commission for the formation of a list of types of medical devices subject to simplified registration under RF Government Resolution No. 552 of April 1, 2022 is extended.
The interdepartmental commission was established in November 2023. It includes one representative from each of the Ministry of Health, the Ministry of Finance, the Ministry of Economic Development, the Ministry of Industry and Trade, the Federal Tax Service, the Federal Customs Service, the Federal Antimonopoly Service and two representatives of Roszdravnadzor itself, as well as one representative from other bodies and organizations - "if necessary". The composition of the commission is approved by an order of Roszdravnadzor.
The commission forms a list of medical devices that can be registered according to the algorithm set out in RF Government Resolution No. 552. Products are included in the list for three reasons: regulators have identified a risk of a medical device being defective on the Russian market during monitoring; the commission has received an application from an authorized person to supply medical devices at a price below the average market price; other reasons are at the discretion of the commission.
Roszdravnadzor last reported updating the list of medical devices covered by the simplified registration mechanism in July 2024. At that time, the list expanded to 2,208 items.
The Russian government introduced a simplified procedure for registering medical devices with the option of obtaining an indefinite dossier and a simplified algorithm for replacing raw materials and components in already registered medical equipment in early April 2022. Initially, the document was supposed to be valid until September 1, 2023, but later Resolution No. 552 was extended until January 1, 2025. In early November 2024, the Russian Ministry of Health prepared a draft government resolution that should extend the validity of a number of innovations concerning simplified registration regimes for medicines and medical devices. In particular, Resolution No. 552 is planned to be extended until the end of 2028.
Market news
The government will allocate 736 million rubles to upgrade the city hospital in Kislovodsk
Russian Prime Minister Mikhail Mishustin signed an order according to which the Russian Ministry of Health will allocate 736.4 million rubles to improve the material and technical equipment of the Kislovodsk City Hospital in the Stavropol Territory. The funds will be allocated from the government's reserve fund. The specified amount will be used to create beds in the intensive care unit, as well as to purchase medical equipment. In 2024, at the expense of the federal budget, they intended to create at least 24 beds in the intensive care unit, purchase and put into operation at least 176 medical devices. The government noted that the decision will make it possible to improve the "availability and quality of medical care." The Russian Ministry of Health was obliged to monitor the targeted and effective use of funds, as well as to submit a thematic report to the Government of the Russian Federation by March 1, 2025. At the end of January 2024, the Government of the Russian Federation adjusted the list of measures for the integrated development of the resort town of Kislovodsk until 2030 and allocated 800 million rubles for the construction of a building with an operating block and an admissions department of the Kislovodsk city hospital. At the same time, the deadline for putting the building into operation was postponed from 2022 to 2024. The construction of the facility began in 2020 - at that time, 962.29 million rubles were allocated for these purposes. In addition, in mid-December 2024, the Russian Government allocated 150 million rubles from the federal budget to complete the construction of another facility in the Stavropol Territory - a children's clinical hospital. It was assumed that the funding would allow the medical facility to be opened by the end of 2024.
Other
A portable bioprinter has been developed at Sechenov University to combat non-healing wounds
The V. A. Rakhmanov Clinic of Skin and Venereal Diseases, the Institute of Regenerative Medicine and the Design Center for Flexible Bioelectronics at Sechenov University are developing a portable bioprinter "Biogan" for bioprinting a tissue equivalent of skin, which will be effective in treating non-healing or poorly healing ulcers, including those of a diabetic nature. To test the system, scientists plan to conduct an experiment on minipigs in the laboratory of regenerative veterinary medicine at Sechenov University.
LETI engineers have developed software and a digital model of a domestic system for improving lung preservation for transplantation
The ReGenesis Box device, created on the basis of a digital model, will help to increase the organ preservation time by 4-12 times compared to similar systems, thereby increasing the percentage of successful transplant outcomes.
Newly registered medical devices
We publish a list of new medical devices registered from 12.27.2024 to 01.10.2025
Link to the list: [see table in the attachment]
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